Trials show Androxal superior in Secondary Hypogonadism - Repros Therapeutics

Repros Therapeutics reported top line results for the first of two identical pivotal studies comparing Androxal (clomiphene) to a leading FDA approved topical gel (Androgel) and placebo in patients with Testosterone Deficiency. In this study, ZA-305, Androxal exhibited superiority in several assessments, particularly the two co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. Multiple secondary endpoints also showed statistically significant differences between the Androxal and T gel groups.

The key results are: 23.8% of Topical T subjects below 10 million sperm/mL at end of study versus 2.3% and 2.4% respectively for Androxal and placebo. There was a 33% reduction from baseline sperm concentration for Topical T subjects versus 5.9% increase for Androxal. The study also showed a 33.3% responder rate for Topical T versus 65.9% rate for Androxal. Based on the findings of ZA-305, the appropriateness of hormone replacement for the secondary hypogonadal male may be brought into question and, at a minimum, these findings suggest that conservative treatment, diet and exercise should be employed initially.